NCT07262736

Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Clozapine is an effective treatment for patients with schizophrenia who do not respond to other therapies, but its blood concentration varies widely between individuals due to genetic and physiological differences. Proton pump inhibitors such as pantoprazole are often prescribed in this population to prevent stomach discomfort, yet their impact on clozapine exposure has not been fully characterized. This clinical study will investigate the pharmacokinetics of clozapine and its main metabolite norclozapine, the influence of individual characteristics on drug exposure, and the effect of pantoprazole coadministration. Healthy adult volunteers will participate in a randomized open label cross over design, receiving a single dose of clozapine alone and again after pantoprazole treatment. Outcomes include clozapine and norclozapine plasma concentration time profiles, pharmacokinetic parameters, and safety assessments.

Conditions

• Healthy Volunteers - Male and Female

Interventions

Type	Name	Description
DRUG	clozapine	Single dose of 12.5 mg clozapine (half 25 mg tablet)
DRUG	pantoprazole	Five daily doses of pantoprazole tablets 40 mg to be started four days prior to the clozapine administration

Timeline

• Start date: 2021-02-06
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: Malaysia